Multimodal Treatments for Chronic Lower Back Pain

(BACPAC Trial)

Overseen By Sana Shaikh, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Michigan

Must not be taking: High-dose opioids

Disqualifiers: Cancer, Pregnancy, Osteoporosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

494 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is being completed to better understand who benefits from different chronic pain treatments and how these treatments work. This study will include a four week run-in period for all cLBP participants. After completing the PainGuide (online or smart phone accessible website) run-in period, participants will be assessed using either the light or light plus deep phenotyping assessment battery and those who minimal or modest improvement in their pain (based on PGIC) will be randomized to one of four 8-week treatments (mindfulness-based stress reduction (MBSR), physical therapy (PT) and exercise, acupressure self-management, or duloxetine). In addition, participants will complete study visits including physical exams, complete surveys, provide samples (blood,saliva, etc.), wear an electronic wrist device at certain times, and have Magnetic resonance imaging (MRIs) during the study. Following one of the 4 treatments (8 weeks) if participants have a certain level of pain (that meets eligibility for more treatment) they will be then randomized to complete one of the 3 treatments that was not already assigned to them. The study hypothesizes the following: that this interventional response phenotyping can identify individuals with different underlying mechanisms for their pain who thus respond differentially to evidence-based interventions for chronic lower back pain (cLBP).

Research Team

Afton Hassett, PsyD

Principal Investigator

University of Michigan

Daniel Clauw, MD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for individuals with chronic lower back pain lasting at least six months, who are right-handed, can lie still for MRI scans, and don't have severe health issues like osteoporosis or uncontrolled addiction. Participants must not be pregnant, involved in other conflicting studies, expecting surgery within a year, or on high opioid doses.

Inclusion Criteria

I can avoid alcohol and nicotine on the day of my test.

You have had ongoing low back pain for at least six months, and it is present on more than half of those days.

I am open to being assigned any of the four treatment options.

Exclusion Criteria

I am not taking any medications that are excluded by the study.

You have a history that makes it unsafe for you to have an MRI scan.

You have had an allergic reaction to duloxetine in the past.

Timeline

Run-in

Participants complete a four-week run-in period using the PainGuide website

4 weeks

1 visit (in-person)

Treatment

Participants are randomized to one of four 8-week treatments: MBSR, PT and exercise, acupressure, or duloxetine

8 weeks

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 weeks

2 visits (in-person)

Additional Treatment

Participants with certain pain levels may be randomized to one of the three treatments not previously assigned

8 weeks

Treatment Details

Interventions

• Duloxetine
• MBSR
• PT and exercise
• Self-administered acupressure

Trial Overview The study tests four treatments: mindfulness-based stress reduction (MBSR), physical therapy with exercise, self-administered acupressure, and the medication duloxetine. After an initial assessment period using PainGuide and MRIs among others tools participants may receive two different treatments sequentially if they still have significant pain.

Participant Groups

Group I: PainGuide Experimental Treatment 1 Intervention

Run-in treatment only with no additional treatments.

Group II: PT and exercise then MBSR Experimental Treatment 4 Interventions

Run-in treatment, then 8 weeks of PT and exercise, and then 8 weeks of MBSR.

Group III: PT and exercise then Duloxetine Experimental Treatment 4 Interventions

Run-in treatment, then 8 weeks of PT and exercise, and then approximately 8 weeks of Duloxetine

Group IV: PT and exercise then Acupressure Experimental Treatment 4 Interventions

Run-in treatment, then 8 weeks of PT and exercise, and then 8 weeks of Acupressure

Group V: PT and exercise Experimental Treatment 3 Interventions

Run-in treatment then PT and exercise

Group VI: MBSR then PT and exercise Experimental Treatment 4 Interventions

Run-in treatment then 8 weeks of MBSR, and then 8 weeks of PT and exercise.

Group VII: MBSR then Duloxetine Experimental Treatment 4 Interventions

Run-in treatment, then 8 weeks of MBSR, and then approximately 8 weeks of Duloxetine

Group VIII: MBSR then Acupressure Experimental Treatment 4 Interventions

Run-in treatment, then 8 weeks of MBSR, and then 8 weeks Acupressure.

Group IX: MBSR (mindfulness-based stress reduction) Experimental Treatment 3 Interventions

Run-in treatment then MBSR.

Group X: Duloxetine then PT and exercise Experimental Treatment 4 Interventions

Run-in treatment, then approximately 8 weeks of Duloxetine, and then 8 weeks of PT and exercise

Group XI: Duloxetine then MBSR Experimental Treatment 4 Interventions

Run-in treatment, then approximately 8 weeks of Duloxetine, and then 8 weeks of MBSR.

Group XII: Duloxetine then Acupressure Experimental Treatment 4 Interventions

Run-in treatment, then approximately 8 weeks of Duloxetine, and then 8 weeks Acupressure.

Group XIII: Duloxetine Experimental Treatment 3 Interventions

Run-in treatment then Duloxetine

Group XIV: Acupressure then PT and exercise Experimental Treatment 4 Interventions

Run-in treatment, then 8 weeks of Acupressure, and then 8 weeks of PT and exercise.

Group XV: Acupressure then MBSR Experimental Treatment 4 Interventions

Run-in treatment, then 8 weeks of Acupressure, and then 8 weeks of MBSR

Group XVI: Acupressure then Duloxetine Experimental Treatment 4 Interventions

Run-in treatment, then 8 weeks of Acupressure, and then approximately 8 weeks of Duloxetine

Group XVII: Acupressure Experimental Treatment 3 Interventions

Run-in treatment then Acupressure

Duloxetine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cymbalta for:

• Major Depressive Disorder
• Generalized Anxiety Disorder
• Fibromyalgia
• Neuropathic Pain
• Chronic Musculoskeletal Pain

Approved in European Union as Cymbalta / Yentreve for:

• Major Depressive Disorder
• Generalized Anxiety Disorder
• Diabetic Peripheral Neuropathic Pain
• Fibromyalgia
• Stress Urinary Incontinence

Approved in Canada as Cymbalta for:

• Major Depressive Disorder
• Generalized Anxiety Disorder
• Fibromyalgia
• Neuropathic Pain
• Chronic Musculoskeletal Pain

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+